effect of bia 9-1067 on cardiac repolarization in healthy adult men and women

Conditions: Parkinson Disease

Summary: the purpose of this study is to evaluate the effect of bia 9-1067 on the cardiac repolarization in adult healthy men and women volunteers.

single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled, 4-period crossover trial in healthy male and female subjects

Eligibility criteria:
inclusion criteria: * a signed and dated informed consent form before any study-specific screening procedure was performed, * healthy male or female 18 to 55 years of age. women had to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation or bilateral oophorectomy at least 6 months prior to enrollment); using an intrauterine device; a non-hormonal double barrier contraceptive method (i.e., diaphragm or spermicide plus male condom) for the duration of the trial and with a negative pregnancy test at screening and upon each check-in to the study facility, * had a bmi within the range of 18-30 kg/m2, * able to communicate effectively with the study personnel, * had no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic, * had a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction, * non-smokers or ex-smokers for at least 3 months, * adequately informed of the nature and risks of the study and gave written informed consent prior to study entry. exclusion criteria: * known hypersensitivity or allergy to moxifloxacin, bia 9-1067 or related compounds such as tolcapone or entacapone, * women who were pregnant or breastfeeding, * any disease or condition (medical or surgical) which, in the opinion of the investigator, might have compromised the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might have interfered with the absorption, distribution, metabolism or excretion of study drug, or would have placed the subject at increased risk, * a sustained supine systolic blood pressure \> 140 mmhg or \ 95 mmhg at screening or baseline, * a resting ecg heart rate of \ 100 bpm, * an abnormal screening ecg indicating a second- or third-degree av block, or one or more of the following: qrs \> 110 milliseconds (ms), qtc (fridericia correction) \> 450 ms for male and 470 ms for females, pr interval \> 240 ms. any rhythm other than sinus rhythm, which was interpreted by the investigator to be clinically significant, * the presence of abnormal laboratory values which were considered clinically significant by the investigator, * positive screen for hepatitis b (hbsag, hepatitis b surface antigen), hepatitis c (anti hcv, hepatitis c antibody), or hiv (anti-hiv 1/2), * received an investigational drug within a period of 30 days prior to enrolment in the study, * received any drug therapy, excluding hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. this exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism, * consumption of alcohol within 48 hours prior to dose administration or during any inpatient period, * a positive urine drug screen including or a positive alcohol breath test, * any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction, * a history of difficulty with donating blood, * donated blood or blood products within 45 days prior to enrollment, * history of tendonitis or tendon rupture associated with treatment with quinolone antibiotics, * subjects with, or with a history of, additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia), or a family history of long qt syndrome or family history of sudden death.

Keywords: parkinson disease bia 9-1067